This study is expected to show auricular acupressure therapy help to improve the anxiety symptoms of perimenopausal and early postmenopausal women, looking forward to developing a convenient, safe and effective way to reduce the use of sedative hypnotics and their dependencies, thereby improving their quality of life.

use the tape of ear adhesive beads on shenmen and subcortical area of both ears after three meals and before bed for three minutes each area with alternating ears, twice a week to replace paste.

Other Name: acupressure

Sham Comparator: sham acupressure

Other: sham acupressure

use only tape without ear adhesive beads under the same ways

Other Name: acupressure

Detailed Description:

There are several stages of women while they were particularly vulnerable to anxiety and insomnia , especially in the pre-menstruation, pregnancy, postpartum, and menopause stage. Sleep problems are common in menopausal and postmenopausal women, its prevalence can be based on research from 15% to 60%. As for anxiety, the prevalence of women in this population can reach 53.7%. Several studies overseas have already pointed out that the improvement of acupuncture for anxiety disorders have had pretty good results. As auricular acupressure with a simple operation and the advantages of non-invasive, our interest is to explore the clinical benefit of combined auricular acupressure and medical therapy on anxiety and insomnia improvement in menopausal and early post-menopausal women. We design a double-blind, randomized controlled study, the subjects are ninety 40 to 60 years old women, during perimenopause and early postmenopause who are accompanied by anxiety symptoms. They were randomly divided into experimental and control groups, use the tape of ear adhesive beads on shenmen and subcortical area of both ears after three meals and before bed for three minutes each area with alternating ears, twice a week to replace paste. A total treatment time is eight times and a total of four weeks. Primary efficacy assessment (primary outcome measure) for the Hamilton Anxiety Rating Scale (HAMA) total score change. Secondary efficacy assessments (secondary outcome measure) for: 1) Menopause Rating Scale (MRS) scores; 2) Short Form Health Survey (SF-36) scores; 3) Clinical Global Impression-Severity (CGI-S) scores; and 4) Clinical Global Impression-Improvement (CGI-I) score changes.

Eligibility

Ages Eligible for Study:

40 Years to 60 Years (Adult)

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

age between 40 to 60 years

irregular menstrual cycle less than 12 months or no menstrual cycle less than 10 years

FSH level>= 14 IU/L

Brief symptom rating scale total scores>= 6

Exclusion Criteria:

severe medical conditions

substance dependence or abuse

contraindication of BZDs

contraindication of acupressure

other primary anxiety disorder and major psychosis

use hormone therapy

use herb medicine

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01056458